CMC Analytical Scientist in Summit, NJ

Must Have's:

pharmaceutical industry analytical experience

Summary:

• A scientist in the Analytical CMC Strategy group is expected to provide critical analytical support for commercial change controls, RoW filing support, and commercial analytical activities.
• The Scientist is required to have pharmaceutical analytical experience with late phase and/or commercial phase of business.
• Experience with change controls, method validation and transfer, and some knowledge in regulatory filings, FDA and ICH guidance, and knowledge of Pharmacopoeia are highly valued.
• Responsibilities include but are not limited to change control management, method review and summary, data verification, data summary and support for specification justification, reviewing dossier and related filing documents.
• The scientist will work in Analytical Science and Technology (AST) group which resides in the Global Quality Organization.
• This role requires ability to work in a highly matrixed environment, a quick learner and a team player.

Duties/Responsibilities

• This position is for the Summit, NJ site of Client
• Operate in a matrix team environment with collaboration with analytical development, global quality product leads, technical project teams, and regulatory groups etc. within Client.
• Support of commercial analytical change controls
• Support life cycle of regulatory filings, participates in preparation/reviewing of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions
• Gathering, interpretation and presentation of data to support decision making

Additional Responsibilities Include

• Maintain effective partnerships with stakeholders from analytical development, Manufacturing Sciences and Technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.
• Share expertise with matrix teams in support of analytical topics related to FDA, MMA, ROW & PAS filing review.
• Support implementation of effective control strategy, analytical method and specification change control as needed throughout the Client network, third party manufacturing and outside testing labs.
• Serve as a subject matter expert for project, including technical evaluations of methods and data.

Qualifications

Specific Knowledge, Skills, Abilities, etc:

• Comprehensive knowledge and experience of analytical methodologies used for the development and commercialization of pharmaceutical products. Demonstrate a broad expertise and experience in analytics routinely used for in-process, release and stability testing of drug substance and drug product, product characterization and strategies to establish process and product knowledge.
• Extensive knowledge of the drug development process, analytical strategy and specification setting for drug substance and drug product
• Familiar with FAD, ICH guidance and major Pharmacopoeias. Working knowledge of CMC regulations and cGMP requirements, as well as experience in supporting regulatory filings and post approval changes.
• Strong communication and leadership skills in a highly interactive and fast paced environment.
• Experience in working with cross-functional strategic teams and collaboration with internal and external partners.

Education/Experience/ Licenses/Certifications

• A PhD, MS, or BS in Analytical Chemistry, Chemistry, or related disciplines with at least 1, 3, or 4 years of pharmaceutical industrial experience in relevant fields, respectively.

Physical Demands and Work Environment

• This is primarily a analytical subject expertise and analytical project management role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting requiring:
• Inside Work
• Working Alone
• Working with/around others

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